FDA Clears Koya Medical’s Compression Therapy System for Lower Extremities

Koya Medical has obtained FDA 510(k) clearance for its Dayspring compression therapy system for treating lymphedema and various diseases that hamper lymphatic flow in the lower extremities.

The device uses a low-profile active garment made of breathable mesh, a rechargeable handheld controller that can be worn on a lanyard and a mobile app that allows for customized programming. Patients using the Dayspring system receive standard-of-care active compression therapy while they wear the device.

Koya’s Dayspring system previously received FDA 510(k) clearance for use in the upper extremities in June 2020.